Mabion withdraws application for rituximab biosimilar in EU

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Mabion withdraws application for rituximab biosimilar in EU

Biosimilars/News | Posted 17/04/2020 0 Post your comment

Polish biologicals company Mabion Spolka Akcyjna (Mabion) has withdrawn its duplicate applications for its rituximab biosimilar, MabionCD20.

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection, and autoimmune disorders.

Mabion signed an agreement with US-based drugmaker Mylan to commercialize MabionCD20 in the European Union (EU) and non-EU Balkan states in November 2016 [1]. Then the company submitted its first application of MabionCD20 to the European Medicines Agency (EMA) for approval in June 2018 [2].

Then on 6 August 2018, Mabion received permission from EMA to submit a second, or duplicate, application for MabionCD20. The second application was submitted in order to acquire an additional trade name, for which the list of indications for the product would be limited and would not include rheumatoid arthritis (RA). This, according to the company, could accelerate the commercialization of MabionCD20 in markets where RA is still covered by the patent protection for MabThera.

However, on 16 April 2020, Mabion withdrew the applications. This decision was taken by the company after EMA ‘had evaluated the information from the company and prepared questions’. EMA said that after it had ‘assessed the company’s responses to the last round of questions, there were still some unresolved issues’.

Based on the review of the data and the company’s response to EMA’s questions, at the time of the withdrawal, the agency still ‘had some concerns and its provisional opinion was that Rituximab Mabion could not have been authorized for the requested indications’. EMA said that it ‘was concerned that biosimilarity between Rituximab Mabion and the reference medicine MabThera had not been established’. In addition, EMA said that it ‘also had concerns about the manufacturing process and the system for ensuring reliable quality of the medicine’. Therefore, at the time of the withdrawal, EMA’s ‘opinion was that the company had not fully addressed its concerns and therefore the benefit of Rituximab Mabion could not be established’.

Despite the rejection by EMA, Mabion said in its letter notifying EMA of the withdrawal of the applications that the applications ‘pertained only to the initial scale of manufacturing process’ and that they ‘will prepare a new application’.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Mabion signs agreement with Mylan for rituximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [2020 Apr 17]. Available from: www.gabionline.net/Biosimilars/News/Mabion-withdraws-application-for-rituximab-biosimilar-in-EU
2. GaBI Online - Generics and Biosimilars Initiative. Mabion submits rituximab biosimilar to EMA for approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 17]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-biosimilar-submitted-to-EMA-and-Rituxan-gains-extra-indication

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Source: EMA, Mabion